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Dosage form: & nbsppills
Composition:

Active components:

- 1 yellow pellet contains 2.0 mg of estradiol valerate.

- 1 brown pellet contains 2.0 mg of estradiol valerate and 0.15 mg of levonorgestrel.

Excipients:

lactose monohydrate, potato starch, polyvidon K 25, talc, magnesium stearate, sucrose, glucose (dextrose), gelatin, macrogol 35000, calcium carbonate, titanium dioxide E171, iron oxide hydrate, iron oxide red, iron oxide brown, carnauba wax, magnesium basic carbonate, purified water.

Description:Round dragee of yellow color (9 tablets) and brown (12 tablets).
Pharmacotherapeutic group:Anti-climacteric (estrogen + progestogen)
ATX: & nbsp
  • Levonorgestrel and estrogen
  • Pharmacodynamics:

    The clinonorm contains estrogen - estradiol valerate, which in the human body turns into a natural 17 (3-estradiol.) Also in the composition of the drug Climonorm is a derivative of 19-nortestosterone - levonorgestrel. Adding levonorgestrel within 12 days of each cycle reduces the risk of developing hyperplasia and endometrial cancer.

    Due to the composition and the cyclical regimen of the Climonorm administration, (taking only estrogen for 9 days, then - combining estrogen and progestogen for 12 days, and finally, 7-day break), women with a unsuccessful uterus with a regular intake of the drug have a menstrual cycle .

    Estradiol replenishes the estrogen deficiency in the female body after the onset of menopause and provides effective treatment of psycho-emotional and vegetative climacteric symptoms (such as "hot flashes", increased sweating, sleep disturbances, increased nervous excitability, irritability, palpitations, cardialgia, dizziness, headache, libido, muscle and joint pain); involution of the skin and mucous membranes, especially the mucosal genitourinary system (urinary incontinence, dryness and irritation of the vaginal mucosa, tenderness in sexual intercourse).

    Estradiol prevents bone loss caused by estrogen deficiency. This is mainly due to the suppression of osteoclast function and the shift of the bone remodeling process towards bone formation. It has been proven that prolonged use of hormone replacement therapy (HRT) can reduce the risk of fracture of peripheral bones in women after menopause. With the abolition of HRT, the rate of bone mass reduction is comparable to that characteristic for the period immediately after menopause.It is not proven that using HRT, it is possible to achieve bone mass recovery to the pre-menopausal level.

    HRT also has a beneficial effect on the content of collagen in the skin, as well as on its density, and can also slow the process of wrinkle formation.

    Admission of the clinonerman leads to a decrease in the level of total cholesterol, low density lipoprotein (LDL), and an increase in high density lipoprotein (HDL), resulting in a significant increase in the ratio of HDL / LDL, as well as increased triglyceride levels.

    Observational studies suggest that among women in postmenopausal women, the use of HRT reduces the incidence of colon cancer. The mechanism of action is still unclear.

    Pharmacokinetics:

    After ingestion estradiol valerate quickly and completely absorbed from the gastrointestinal tract (GIT). After entering the body, it quickly metabolizes with the formation of 17P-estradiol and estrone, which are further subjected to standard metabolic transformations. After oral administration, about 3% of estradiol becomes bioavailable.The maximum concentration of estradiol is achieved after 2-3 hours, the ratio of estrone-estradiol is 4: 1. Estradiol is output as metabolites, mainly in the urine (90%) and, to a lesser extent - in the bile.

    After oral administration levonorgestrel quickly and almost completely absorbed from the digestive tract. The maximum concentration in the serum is achieved in 1-2 hours. 93-95% of levonorgestrel binds to albumin and sex hormone binding globulin (GSHG). Metabolites of levonorgestrel are excreted in urine and bile, mainly in the form of sulfates and glucuronides.

    Indications:
    • Hormone replacement therapy (HRT) for climacteric disorders, involutional changes of the skin and the urogenital tract, depressive states in climacteric and symptoms of estrogen deficiency due to natural menopause or hypogonadism, sterilization or primary ovarian dysfunction in women with a uterus unremoved.
    • Prevention of postmenopausal osteoporosis.
    • Normalization of irregular menstrual cycles.
    • Treatment of primary or secondary amenorrhea.
    Contraindications:

    It is not recommended to start hormone replacement therapy (HRT), in the presence of any of the conditions listed below. If any of these conditions occurs during HRT, the drug should be discontinued immediately.

    • Pregnancy and lactation.
    • Vaginal bleeding of unknown origin.
    • Proven or suspected diagnosis of breast cancer.
    • Confirmed or suspected diagnosis of hormone-dependent precancer of the disease or hormone-dependent malignant tumor.
    • Tumors of the liver are presently or in the anamnesis (benign or malignant).
    • Severe liver disease.
    • Acute or recent arterial thrombosis or thromboembolism (such as myocardial infarction, stroke).
    • Deep vein thrombosis in the acute stage, thromboembolism now or in the anamnesis.
    • Expressed hypertriglyceridemia.
    • Hypersensitivity to the components of the drug Klimonorm.
    Carefully:The clinonorm should be administered with caution in the following conditions: arterial hypertension, congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson syndrome and Rotor syndrome),Cholestatic jaundice or cholestatic itching during pregnancy, endometriosis, uterine fibroids, diabetes mellitus (see "Special instructions").
    Pregnancy and lactation:

    HRT is not prescribed during pregnancy or lactation.

    Large-scale epidemiological studies of steroid hormones used for contraception or HRT did not reveal an increased risk of developing birth defects in children born in women who took such hormones before pregnancy, as well as teratogenic effects of hormones when they were accidentally taken in the early stages of pregnancy.

    A small amount of sex hormones can be excreted in the mother's milk.

    Dosing and Administration:

    If the patient still has menstruation, the treatment should begin on the 5th day of the menstrual cycle (the 1st day of menstrual bleeding corresponds to the 1st day of the menstrual cycle).

    Patients with amenorrhea or very rare menstruation, as well as postmenopausal women, can start taking the drug at any time, provided that pregnancy is excluded (see section "Pregnancy and lactation").

    Each package is designed for a 21-day reception.

    Every day during the first 9 days one yellow pellet is taken, and then for 12 days - one brown pellet daily. After 21 days of taking the drug, a 7-day break in taking the drug follows, during which menstrual bleeding occurs, caused by cancellation of the drug (usually 2-3 days after taking the last pills).

    After a 7-day break in taking the drug, they begin a new package of the Climonorma, taking the first pills on the same day of the week as the first pills from the previous package.

    Dragee swallowed whole, squeezed a small amount of liquid. The time of day when a woman takes the drug does not matter, however, if she starts taking the pills at any particular time, she should stick to this time and on. If the woman forgot to take the pills, she can take it within the next 12 - 24 hours. If treatment is interrupted for a longer time, vaginal bleeding may occur.

    Side effects:

    On the part of the reproductive system and mammary glands:

    changes in the frequency and intensity of uterine bleeding, breakthrough bleeding,intermenstrual bloody discharge (usually weakened during therapy), dysmenorrhea, changes in vaginal discharge, a condition similar to premenstrual syndrome; tenderness, tension and / or enlargement of the mammary glands.

    From the gastrointestinal tract:

    dyspepsia, bloating, nausea, vomiting, abdominal pain, relapse of cholestatic jaundice.

    From the skin and subcutaneous tissue:

    skin rash, skin itch, chloasma, erythema nodosum.

    From the side of the central nervous system:

    headache, migraine, dizziness, anxiety or depressive symptoms, increased fatigue.

    Other:

    heart palpitations, swelling, increased blood pressure, venous thrombosis and thromboembolism, muscle cramps, weight changes, changes in libido, visual impairment, contact lens intolerance, allergic reactions.

    Overdose:Studies of acute toxicity did not reveal a risk of acute side effects with the occasional administration of the drug Climonorm in an amount many times greater than the daily therapeutic dose. Symptoms that may occur during an overdose: nausea, vomiting, vaginal bleeding.There is no specific antidote, treatment is symptomatic.
    Interaction:

    At the beginning of HRT, it is necessary to stop the use of hormonal contraceptives. If necessary, the patient should recommend non-hormonal contraceptives.

    Long-term treatment with drugs that induce liver enzymes (for example, some anticonvulsant and antimicrobial drugs) can increase the clearance of sex hormones and reduce their clinical effectiveness. A similar property of inducing liver enzymes was found in hydantoids, barbiturates, primidon, carbamazepine and rifampicin, the presence of this feature is also assumed in oxcarbazepine, topiramate, felbamate and griseofulvin. The maximum induction of enzymes is usually observed not earlier than 2-3 weeks, but then it can persist for at least 4 weeks after discontinuation of the drug.

    In rare cases, along with the concomitant use of certain antibiotics (for example, penicillin and tetracycline groups), a decrease in the level of estradiol was observed.

    Substances that are highly conjugated (for example, paracetamol), can increase the bioavailability of estradiol due to competitive inhibition of the conjugation system in the absorption process.

    Due to the effect of HRT on glucose tolerance, in some cases, the need for oral antidiabetics or insulin may change.

    Interaction with alcohol

    Excessive consumption of alcohol during HRT may lead to an increase in the level of circulating estradiol.

    Special instructions:

    The clinonorm is not used for contraception.

    If contraception is necessary, non-hormonal methods should be used (with the exception of calendar and temperature methods). If you suspect a pregnancy, you should stop taking the pills until pregnancy is not ruled out (see "Pregnancy and lactation").

    In the presence or deterioration of any of the following conditions or risk factors, the relationship between individual risk and benefit of treatment should be evaluated before starting or continuing HRT.

    Venous thromboembolism

    In a number of controlled randomized, and wage epidemiological studies, an increased relative risk of venous thromboembolism (VTE) in the background of HRT, i.e. deep vein thrombosis or pulmonary embolism.Therefore, when HRT is prescribed for women with risk factors for VTE, the risk-benefit ratio should be carefully weighed and discussed with the patient.

    Risk factors for VTE development include individual and family history (the presence of VTE in close relatives at a relatively young age may indicate a genetic predisposition) and severe obesity. The risk of VTE also increases with age. The question of the possible role of varicose veins in the development of VTE remains controversial.

    The risk of VTE may temporarily increase with prolonged immobilization, "large" planned and traumatological operations or massive trauma. Depending on the cause or duration of immobilization, it should be decided whether to temporarily discontinue HRT

    It should immediately stop treatment if symptoms of thrombotic disorders occur or if they are suspected.

    Arterial thromboembolism

    In randomized controlled trials with long-term use of combined conjugated estrogens and medroxyprogesterone acetate, there was no evidence of a positive effect on the cardiovascular system. In large-scale clinical trials of this compound, a possible increase in the risk of coronary disease in the first year of use was found. An increased risk of stroke was also detected. To date, long-term, randomized, controlled trials have not been conducted with other HRT medications in order to detect a positive effect on morbidity and mortality related to the cardiovascular system. Therefore, it is not known whether this increased risk extends to preparations for HRT containing other types of estrogens and progestogens.

    Endometrial cancer

    With prolonged monotherapy with estrogens, the risk of developing hyperplasia or endometrial carcinoma increases. Studies have confirmed that the addition of gestagens reduces the risk of hyperplasia and endometrial cancer.

    Mammary cancer

    According to clinical trials and observational studies, an increase in the relative risk of breast cancer in women using HRT for several years has been found.This may be due to earlier diagnosis, the biological effect of HRT, or a combination of both. The relative risk increases with the duration of treatment (by 2.3 s, about a year of use ^ is possibly even greater with the combination of estrogens with progestogens, an increase comparable to the increase in the risk of breast cancer in women with each year of delay in natural menopause (by 2.8% for a year of delay), as well as obesity and alcohol abuse.The increased risk gradually decreases to the usual level during the first 5 years after the termination of HRT.

    According to studies, breast cancer detected in women taking HRT is usually more differentiated than that of women who do not take it.

    HRT increases the mammographic density of the mammary glands, which in some cases may have a negative impact on the radiographic detection of breast cancer.

    Tumor of the liver

    Against the background of the use of sex steroids, which include means for HRT, in rare cases benign, and even more rarely - malignant tumors of the liver.In some cases, these tumors led to a life-threatening intra-abdominal bleeding. With pain in the upper abdomen, enlarged liver, or signs of intra-abdominal bleeding in differential diagnosis, the probability of a liver tumor should be taken into account.

    Cholelithiasis

    It is known that estrogens increase the lithogenicity of bile. Some women are predisposed to the development of cholelithiasis in treatment with estrogen.

    Other states

    Immediately discontinue treatment, with the appearance of migraine-like or frequent and unusually severe headaches for the first time, as well as with the appearance of other symptoms-possible precursors of thrombotic cerebral stroke.

    The relationship between HRT and the development of clinically significant arterial hypertension has not been established. Women taking HRT, described a small increase in blood pressure, a clinically significant increase is noted rarely. However, in some cases, with the development of HRT in the presence of a clinically significant hypertension, cancellation of HRT can be considered.

    In case of mild violations of the liver function, including various forms of hyperbilirubinemia, such as Dubin-Johnson syndrome or Rotor syndrome, a doctor's supervision is necessary, as well as periodic studies of liver function. With worsening of liver function parameters HRT should be abolished.

    In case of recurrence of cholestatic jaundice or cholestatic pruritus observed for the first time during pregnancy or previous treatment with sex steroid hormones, HRT should be discontinued immediately.

    Special care is required for women with moderately elevated triglycerides. In such cases, the use of HRT may cause a further increase in triglyceride levels in the blood, which increases the risk of acute pancreatitis.

    Although HRT may affect peripheral insulin resistance and glucose tolerance, there is usually no need to change the regimen for the treatment of diabetic patients with HRT. Nevertheless, women suffering from diabetes mellitus should be monitored during HRT.

    In some patients, HRT may cause unwanted estrogen stimulation, such as abnormal uterine bleeding.Frequent or persistent abnormal uterine bleeding against the background of treatment is an indication for endometrial research.

    If treatment of irregular menstrual cycles does not give results, a survey should be conducted to eliminate the organic disease.

    Under the influence of estrogen, uterine fibroids may increase in size. In this case, treatment should be discontinued.

    It is recommended to stop treatment with the development of recurrence of endometriosis in the background of HRT.

    If you suspect a prolactinoma before starting treatment, you should exclude this disease.

    In some cases, there may be a chloasma, especially in women with a history of pregnant women with chloasma. During HRT, women with a tendency to develop chloasma should avoid prolonged exposure to sunlight or ultraviolet radiation.

    The following conditions may or may not occur with HRT. Although their relationship with HRT has not been proven, women with these conditions should be under the supervision of a physician when carrying out HRT: epilepsy; benign breast tumor; bronchial asthma; migraine; porphyria; otosclerosis; systemic lupus erythematosus, small chorea.

    Medical examination and counseling

    Before starting or resuming HRT, a woman should undergo a thorough general medical and gynecological examination (including breast examination and cytological examination of cervical mucus), and exclude pregnancy. In addition, violations of the blood coagulation system should be avoided. Periodically, follow-up examinations should be conducted.

    Influence on the results of laboratory studies

    Reception of sex steroids can affect the biochemical parameters of the function of the liver, thyroid, adrenal and kidney, for the transport of plasma proteins such as corticosteroid-binding globulin and lipid / lipoprotein fractions, carbohydrate metabolism, coagulation and fibrinolysis.

    Effect on the ability to drive transp. cf. and fur:Does not affect.
    Form release / dosage:Dragee.
    Packaging:
    A calendar package (blister) containing 9 yellow dragees and 12 dragees of brown color. For 21 dragees or 3 blisters for 21 tablets along with the instructions for use are placed in a cardboard box.
    Storage conditions:At a temperature not higher than 25 ° C in a place inaccessible to children.
    Shelf life:5 years.Do not use after the expiry date printed on the package!
    Terms of leave from pharmacies:On prescription
    Registration number:П N016299 / 01
    Date of registration:09.04.2010 / 09.06.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:Alvogen IPKo S.A.L.Alvogen IPKo S.A.L. Luxembourg
    Manufacturer: & nbsp
    Information update date: & nbsp28.01.2018
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